Changes in percentage and level of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes, assessed at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM).

The primary outcome measure is the proportion of patients that have a rise in interferon gamma levels within the tumor microenvironment of 4 pg/ml or higher before the first dose of Nivolumab as compared to after the first dose, the safety of th...

1)change in IFNg in body 2)response of immune environment of brain tumor tissue to Nivolumab 3)To evaluate clinical response of pts 4)the difference in survival between responders and non-responders 5)differences in the immune cells and secreted...

15

All

22 Years and older (Adult, Older Adult)

NCT03493932

18007718-N-0077

August 17, 2018

June 1, 2021

June 1, 2021

April 11, 2018

August 14, 2018

National Institutes of Health Clinical CenterBethesda, Maryland, United States

Safety of infusion of autologous anti-EGFRvIII CAR T cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria.

Number of patients experiencing dose-limiting toxicity defined as either any unmanageable grade 3-4 toxicity at the end of the second treatment cycle or inability to receive at least 7 of the 10 drugs, all of them being given at ≥50% of the target doses

Overall survival according to Kaplan-Meier estimates

Progression-free survival according to Kaplan-Meier estimates

Best tumor response according to the Revised Assessment in Neuro-Oncology (RANO) criteria

To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme

200

All

18 Years to 99 Years (Adult, Older Adult)

NCT00083512

04020004-C-0200

June 22, 2004

May 25, 2004

August 9, 2018

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland, United States

Toxicity of EDO-S101 for MGMT Unmethylated Glioblastoma (nGBM) Evaluated According to the Most Current Version of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Criteria.

Overall Response Rate (ORR)

(and 2 more...)

128

All

18 Years and older (Adult, Older Adult)

NCT03452930

2017-0555NCI-2018-00872

August 13, 2018

October 2020

October 2020

March 2, 2018

August 14, 2018

University of Texas MD Anderson Cancer CenterHouston, Texas, United States

Number of Participant with Dose Limiting Toxicities defined as Any of the following treatment-related adverse events (AEs) is evaluated and reported from Day 1 through Day 26; as assessed by NCI-CTCAE, version 4.03

Number of patients without documented tumor progression at 6 months from date of first TG6002 infusion according to Response Assessment Neuro-Oncology Criteria (Wen et al., 2010, JCO, PMID:20231676)

TG6002 recommended dose prior to the Phase 2a part of the study (RP2D) in combination with 5-FC (Maximum Plasma Concentration [Cmax])

Safety and tolerability of IMA950 administered with granulocyte macrophage colony stimulating factor (GM-CSF) and topical imiquimod together following a single low-dose application of cyclophosphamide.

Immunogenicity of IMA950

Immune status parameters

(and 4 more...)

6

All

18 Years and older (Adult, Older Adult)

NCT01403285

IMA950-10211C0192

August 2011

April 2014

April 2014

July 27, 2011

May 19, 2014

Neuro-Oncology Branch of the National Cancer Institute, National Institutes of HealthBethesda, Maryland, United States